Know Cancer

forgot password

A Phase II Study of Docetaxel in Combination With ZD 1839 (IRESSA) in Previously Treated Patients With Metastatic Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Metastatic Pancreatic Carcinoma

Thank you

Trial Information

A Phase II Study of Docetaxel in Combination With ZD 1839 (IRESSA) in Previously Treated Patients With Metastatic Pancreatic Cancer

Iressa will be taken orally once daily without interruption. Docetaxel will be administered
intravenously once weekly for two out of every three weeks. Patients will also receive
dexamethasone the night prior, morning of, and the evening after docetaxel treatment to help
prevent an allergic reaction.

Every week that chemotherapy is given, blood tests and vital signs will be taken.

After the first 6 weeks of therapy a CT scan (or other radiological procedure) will be done
to assess the progress of the disease. If the cancer is responding to the treatment and no
unacceptable side effects have occured, treatment with Iressa and docetaxel will continue.

CT scans (or other radiological procedure) will be performed at week 12 and every 9 weeks
thereafter to monitor the progress of the disease.

Inclusion Criteria:

- Metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors); histologic
confirmation of either the primary or metastatic site.

- ECOG performance status of < 1

- > 4 weeks since completion of previous chemotherapy

- > 4 weeks since participation in any investigational drug study

- Peripheral neuropathy of grade < 1

- Patients must have failed a gemcitabine-containing regimen administered in the
metastatic, adjuvant, or locally advanced setting.

- Absolute neutrophil count (ANC) > 1,500/mm3

- Hemoglobin > 9.0gm/dl

- Platelets > 100,000/mm3

- Total bilirubin < 2.0mg/dl

- AST and alkaline phosphatase < 5 x upper limit of normal (ULN)

- Albumin > 2.5gm/dl

- CA 19-9 > 1.5 x ULN

Exclusion Criteria:

- Prior therapy with taxane or with epidermal growth factor receptor (EGFR) inhibitors

- More than one prior chemotherapy treatment

- Clinically significant cardiac disease

- Major surgery within 4 weeks of the start of study treatment

- Evidence of central nervous system (CNS) metastases or carcinomatous meningitis or
history of uncontrolled seizures, central nervous system disorders.

- Uncontrolled serious medical or psychiatric illness

- Pregnant or breast-feeding women

- Other active malignancy

- Inability to swallow tablets or evidence of a gastrointestinal malabsorption syndrome

- Known severe hypersensitivity to Iressa

- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital,
or St. John's wort.

- History of severe hypersensitivity reaction to drugs formulated with polysorbate 80

- Any evidence of clinically active interstitial lung disease

- Ascites requiring paracentesis

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the response rate of Iressa and docetaxel in patients with advanced pancreatic cancer following failure of gemcitabine-based therapy

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Matthew Kulke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

October 2004

Completion Date:

March 2009

Related Keywords:

  • Metastatic Pancreatic Carcinoma
  • Pancreatic Carcinoma
  • Iressa
  • Docetaxel
  • Carcinoma
  • Pancreatic Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617